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CompletedNCT00190411Updated Jan 16, 2013

Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

A Phase 4 interventional study of celiprolol and Control in EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT and CHROMOSOME 2q31.2 DELETION SYNDROME, sponsored by Assistance Publique - Hôpitaux de Paris. Completed. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-01-16.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
15 Years to 65 Years
Sex
All
01

Study summary

Ehlers-Danlos syndrome vascular type (EDS-IV) is caused by a genetic defect of collagen type III. Patient die (median 40 yrs) of vascular complications. There is no treatment. We showed that arteries are thin and overloaded in this patients. We test the protective effect of celiprolol on cardiovascular events in a 5 years, randomized, PROBE design

Read the detailed description

100 patients with verified EDS-IV syndrome are included. Patients are randomized to either celiprolol (50 to 400 mg BID)or no treatment. Patients who are not randomized enter a longitudinal survey of events. The hypothesis is a 50% reduction in the occurrence of cardiovascular events under treatment, assessed by a blinded, independent events committee.

02

Conditions studied

  • EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT
  • CHROMOSOME 2q31.2 DELETION SYNDROME

Keywords

  • Arteries
  • ultrasonography
  • Ehlers Danlos syndrome
  • Cardiovascular disease
  • beta adrenergic antagonists
03

In context

Ehlers-Danlos Syndrome

75 studies on the registry are indexed under Ehlers-Danlos Syndrome; 25 are open to participants now.

This study's enrollment of 54 is close to the median of 52 across 42 interventional studies indexed under Ehlers-Danlos Syndrome.

Browse Ehlers-Danlos Syndrome studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Proven disease,
  • No betablocker at inclusion if previous CV event

Exclusion criteria

Exclusion criteria:

Criteria of not inclusion for the RIGHTEOUS group:

  • Patient having already presented an arterial break or a dissection and treated(handled) by bétâ-blocking(surrounding).
  • Against indication in the use of CELIPROLOL:
  • Unchecked cardiac insufficiency by the treatment
  • cardiogenic shock
  • BAV of 2nd and 3rd not sailed degrees
  • angor of Prinzmetal
  • disease of the sine
  • bradycardia
  • pheochromocytoma untreated
  • low blood pressure
  • sentimentality in the CELIPROLOL
  • Antecedent of anaphylactic reaction
  • myasthenia
  • treatment by FLOCTAFENINE ( Idarac), Sultopride ( interactions ) In these two cases, the patient can be included in the group followed by troop.

Criteria of not inclusion for both groups:

  • Refusal to participate in the study.
  • Impossibility to move.
  • Pregnancy
  • Woman in age to procreate without means of effective contraception.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Treatment

    Celiprolol

    Drug: celiprolol · Drug: Control

Interventions

  • Drugceliprolol

    celiprolol

    Also known as: celiprolol? Dose ranging 100 to 400 mg, dose adaptation, every 6 months by increment of 100 mg, based on tolerance

  • DrugControl

    Untreated controls excluding betablockers

06

What researchers measure

Primary outcomes

  1. reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up

    reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up

    Time frame: during de study

Secondary outcomes

  1. Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.

    Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.

    Time frame: during the study

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Ong KT, Perdu J, De Backer J, Bozec E, Collignon P, Emmerich J, Fauret AL, Fiessinger JN, Germain DP, Georgesco G, Hulot JS, De Paepe A, Plauchu H, Jeunemaitre X, Laurent S, Boutouyrie P. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010 Oct 30;376(9751):1476-84. doi: 10.1016/S0140-6736(10)60960-9. Epub 2010 Sep 7. Erratum In: Lancet. 2016 Aug 6;388(10044):564. doi: 10.1016/S0140-6736(16)31221-1.. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text. PubMed 20825986 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00190411
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Aventis Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 19, 2005
Start date
Oct 2003
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Jan 16, 2013

Study contacts

Pierre BOUTOUYRIE, MD,PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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